EBME Forums Forums Free discussion Free discussion Medical Device Regulations 2017

Link to online pdf document, for those who have an interest in the regulation changes concerning the manufacture, documentation, and post market surveillance of medical devices, and in-vitro diagnostic devices. It may possibly be of use to some!

Medical Device EU Regulations 2017/745

IVD EU Regulations 2017/746

It seems that the "Lead person" (that's EU Speak, preumably) was John Dalli ... someone who is worth checking out via Google (or wherever).

OK, Sean ... have you waded through it all? Anything useful (or new), or is it - the first one - simply another rehash of the same old, same old?

Hopefully, when we eventually leave the "Union", we can revert to HTM-8. At least that didn't take all night to stagger through!

OK Sean, I saved the first document to .pdf then spent twenty minutes having a quick look through (using keywords such as risk, maintenance and what-have-you).

I picked out a few points:-

1) Most of document places extra (and mandatory) demands on manufacturers
- Post-market surveillance
- Periodic safety update report ... and so forth

2) They are putting together a database called Eudamed
- which they hope will be ready early in 2020

3) They are proposing (yet another) coding system
- The Unique Device Identification (UDI) system
- I could not find any details about the format of the UDI
- My guess is that it may be a bar-code (like an equipment serial number)
- But perhaps based on the five digit GMDN*

4) They seem to be supportive of a "risk-based" approach in general

5) I could not find too much about "maintenance" per se

6) "Electrical safety" hardly gets a mention

7) There is a nice drawing of the CE mark!

Although I did not see much of practical value to hospital biomed techs, I'm hoping that others will be able to spend more time on the document, and present their comments right here!

* GMDN (.pdf) "GMDN is now the global language"!

Hello Geoff!

That's a fair summary!
The main regulatory changes would be around eligibility to place devices on the market.
In the Biomed world, those scrutinising pre-purchase-questionnaire's would need to be aware of these changes, and timelines for implementation.

The following link gives a summary and has a nice infographic!
Introductory Guide to New Medical Device Regulations

'Afternoon Sean.

Dare I enquire how all of this may (should?) be impacted by "Brexit"?